DQS offers various services in the field of approval of medical devices and certification of management systems in healthcare.

MDSAP- Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) offers the opportunity to demonstrate compliance with the regulatory requirements of up to five participating countries through a certification process: Australia, Brazil, Japan, Canada and the USA. The advantages of the program are not only the recognition of the results in the registration of medical devices but also the reduction of on-site inspections by the participating authorities.

medicine-explore-dqs-shutterstock-626388572.jpg
Loading...

Introduction to the Medical Device Single Audit Program MDSAP

Blog
Fotolia_195161042_Subscription_Monthly_XXL
Loading...

How to access the Japanese market with medical devices (for overseas companies)

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Change of certifier and/or notified body

Health care certifications

Blog
Vector English Revolutionizing Healthcare The Impact of Machine Learning-Enabled Medical Devices now
Loading...

Revolutionizing Healthcare: The Impact of Machine Learning-Enabled Medical Devices now and in the future

Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen
Loading...

MED unannounced audits

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Change of certifier and/or notified body

Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen
Loading...

CE marking: Notes on handling unannounced audits

Primary packaging materials for medicinal products

ISO 15378

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Change of certifier and/or notified body

CE marking

Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen
Loading...

MED unannounced audits

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Change of certifier and/or notified body

Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen
Loading...

CE marking: Notes on handling unannounced audits

ISO 13485

ISO 13485:2016 defines the requirements for a quality management system to demonstrate an organization's ability to provide medical devices and related services that consistently meet the requirements of both customers and applicable regulatory provisions.

 

Blog
Many trucks and trailers are parked at the base, logistics and production center.
Loading...

Efficient Supplier Management for Medical Devices Manufacturers

Blog
Fotolia_195161042_Subscription_Monthly_XXL
Loading...

How to access the Japanese market with medical devices (for overseas companies)

Blog
header-join-dqs-ein mann spricht mit dem team
Loading...

Change of certifier and/or notified body